Data / Medical devices / China / Alleva Medical (D.G.) Ltd
Alleva Medical (D.G.) Ltd: FDA-registered device maker in Dongguan City Guangdong, China, 7 510(k) clearances
Alleva Medical (D.G.) Ltd is registered with the FDA (registration 3010308146) in Dongguan City Guangdong, China. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010308146
- Address
- 76 San Lian Nan Road, Lu Wu Administration District, Changping Town, Dongguan City Guangdong, China, 523587
- Owner or operator
- ALLEVA MEDICAL LTD (10045844)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 5, 2014
- Registered through
- 2026
- Brand names listed
- 1000mL "Bag" Suction Liner (MI285-0008), 1000mL "Bag" Suction Liner with solidifier (MI285-0015), 1000mL Suction Canister (MI129-0013), 1000mL Suction Lid Liner (MI217), 1200mL Rigid Suction Canister (MI056-0012), 1300mL Suction Canister (MI129), 1300mL Suction Liner (MI157), 1500mL "Bag" Suction Liner (MI286-0008) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 8, 2023 | K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Alleva Medical, Ltd. | accessdata.fda.gov |
| August 27, 2019 | K191107 | Plexus | JOW | Substantially Equivalent | Alleva Medical (D.G), Ltd. | accessdata.fda.gov |
| February 3, 2015 | K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister | OMP | Substantially Equivalent | Devon Medical Products | accessdata.fda.gov |
| September 19, 2014 | K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit | OMP | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| May 15, 2014 | K132225 | EXTRICARE | OMP | Substantially Equivalent | Devon Medical, Inc. | accessdata.fda.gov |
| September 27, 2013 | K132252 | EXTRICARE 100CC/ 250CC/ 400CC CANISTERS | OMP | Substantially Equivalent | Devon Medical | accessdata.fda.gov |
| February 10, 2012 | K110078 | EXTRICARE | OMP | Substantially Equivalent | Devon Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Vacuum
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Tape And Bandage, Adhesive
- All makers of Pump, Breast, Powered
Updated March 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.